Testing the safety and effects of HD-P023 with Teneligliptin and Empagliflozin in healthy adults
A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of HD-P023 in Comparison With Co-administration of Teneligliptin and Empagliflozin High in Healthy Volunteers
This study is testing how safe a new drug called HD-P023 is when taken with Teneligliptin and Empagliflozin in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Handok Inc. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06889350 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the pharmacokinetics and safety of HD-P023 when administered alongside Teneligliptin and Empagliflozin in healthy adult volunteers. Participants will receive these medications to assess how they interact and their effects on the body. The study is designed to gather data on the absorption, distribution, metabolism, and excretion of the drugs involved. By focusing on healthy individuals, the study seeks to establish a baseline for understanding the drugs' safety profiles.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 19 years or older who can provide informed consent.
Not a fit: Patients with clinically significant health issues or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and pharmacokinetics of these medications, potentially leading to improved treatment options for patients in the future.
How similar studies have performed: While this study focuses on a specific combination of drugs, similar pharmacokinetic studies have shown success in understanding drug interactions and safety profiles.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who are 19 years or older on screening * Signed informed consent * Healthy Volunteer * Other inclusion applies Exclusion Criteria: * Clinically relevant/significant findings as evaluated by the investigator * Other exclusion applied
Where this trial is running
Seoul
- H Plus Yangji Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Nari Jung
- Email: nari.jung@handok.com
- Phone: +82-2-527-5263
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.